Field of the Technology
The present disclosure relates generally to a system including at least one syringe for use with a powered fluid injector and, more specifically, to a syringe assembly including conductive coding for identifying information regarding the at least one syringe assembly.
Description of Related Art
In many medical procedures, such as drug delivery, it is desirable to inject various medical fluids, for example, gene therapy, cell and biological agent delivery, and delivery of therapeutic agents generally, into a patient. Likewise, numerous types of contrast media (often referred to simply as contrast) are injected into a patient for many diagnostic and therapeutic imaging procedures. For example, contrast media are used in diagnostic imaging procedures such as X-ray procedures (including, for example, angiography, venography, and urography), computed tomography (CT) scanning, magnetic resonance imaging (MRI), and ultrasonic imaging. Contrast media are also used during therapeutic imaging procedures, including, for example, angioplasty and other interventional radiological procedures.
In recent years, a number of injector-actuated syringes and powered injectors for pressurized injection of fluids, such as contrast media, have been developed. By way of example, in a typical angiographic procedure, the medical practitioner places a cardiac catheter into a vein or artery. The catheter is connected to either a manual or an automatic contrast injection mechanism. Alternatively, in CT and MRI imaging procedures, contrast may be injected into a patient's vasculature, for example through a needle or peripheral cannula. Such imaging agents may be accompanied by or followed by injection of a medical flushing fluid, such as saline. The automatic contrast injection mechanism typically includes at least one syringe assembly connected to a powered injector having, for example, at least one powered linear actuator. Typically, an operator enters settings into an electronic control system of the powered injector for a fixed volume of contrast and/or saline and a fixed rate of injection. In many systems, there is no interactive control between the operator and the powered injector, except to start or stop the injection. In these cases, the injector utilizes a programmed injection protocol to complete the procedure. A change in flow rate in such systems occurs by stopping the machine and resetting the injection parameters. Automation of angiographic procedures using powered injectors is discussed, for example, in U.S. Pat. Nos. 5,460,609, 5,573,515, and 5,800,397, incorporated herein by reference.
Generally, liquids being injected into a patient, such as X-ray and magnetic resonance contrast, are clear pharmaceuticals delivered to a patient during or just prior to a medical imaging procedure. The liquids may be provided in syringes of different sizes to accommodate different volumes of fluid that are required for different patients. Such contrasts can be detected by sophisticated imaging systems, but are difficult to detect with the human eye. Different contrasts have different properties, which make it difficult for a single or standard detector system to measure a property of the contrast. On the other hand, it is desirable that the contrast be clear to enable the user to check for air bubbles, particulates, or other impurities before injecting the fluid into the patient. These impurities could be solid particles or chemicals with an identifiable color. For example, if certain X-ray contrast media is stored improperly, free iodine can be released, causing the contrast to have a yellow tint. For the visualization of air bubbles, particles, or chemicals, the contrast only needs to be transparent, but may be colored.
It is often necessary for the medical practitioner to validate each syringe assembly connected to the automatic fluid injection mechanism prior to performing the injection. Validation may include confirming that the syringe assembly is genuine (e.g. to prevent counterfeiting, use of inferior or miss-fitting syringes that may result in improper mating between the syringe assembly and injector or may not have the required tolerances for a particular injection procedure, possibly resulting in malfunction during the procedure) and determining various characteristics of the syringe assembly and fluid contained therein. For example, the medical practitioner may verify that identifying information, such as the syringe dimensions (e.g. diameter, length, and fluid volume), and fluid contents are correct for the procedure being performed. In addition, the medical practitioner may be required to provide certain information about the syringe assembly, such as frictional characteristics between the plunger and syringe barrel, fluid viscosity, delivery rate, and the like (referred to hereinafter as “injection parameters”) to the fluid injector to control piston force and acceleration to deliver fluid at a desired and controlled flow rate. Other important identifying information may include manufacturer, lot number, expiration date or shelf-life indicator, etc. Including the various desired identifying information may be difficult given the amount of available surface area and aesthetic reasons. For example, if the identifying information covers too much surface area on the syringe, it may impact the technician's ability to determine if the syringe has been properly filled.
In some systems, the fluid injector includes a sensor or reader located on the fluid injector for automatically reading a label or tag provided on the syringe when the syringe assembly is inserted in the injector. The label or tag contains certain information about the syringe assembly. The fluid injector uses the information extracted from the label or tag to validate the syringe assembly and to control the injection. Some existing syringe identification procedures require specific labels or tags that are applied to the syringe assembly subsequent to manufacturing the syringe assembly. In certain cases, the medical practitioner must rotate the syringe assembly until the sensor or reader on the fluid injector is properly aligned with the syringe identification feature, resulting in extended pre-injection manipulation and possible syringe misidentification. The at least one label or tag may include a plurality of label or tag. Each label or tag may correspond to different information regarding the syringe assembly.
Therefore, there is a continued need for a syringe assembly, injector, and/or injection system capable of identifying and validating the size/volume of the syringe assembly, the source of the provided syringe assembly, and the medical fluid solution provided in the syringe assembly prior to injection, wherein ease of use and/or amount of information contained in the identification feature is increased. The syringe assemblies, injectors, and systems set forth in the present disclosure are configured to address some or all of the above-identified problems.